| CTRI Number |
CTRI/2024/08/071825 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
01/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
to study the effectiveness of propofol administered at the end of the surgery for prevention of emergence agitation in children undergoing adenotonsillectomy |
|
Scientific Title of Study
|
A randomized controlled study to evaluate effectiveness of propofol administered at the end of the surgery for prevention of emergence agitation in children undergoing adenotonsillectomy in department of anaesthesia, SMS Medical College, Jaipur. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mamta Sharma |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
Department of Anaesthesia, SMS medical college, JLN marg, jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829566077 |
| Fax |
|
| Email |
drmamtasharma@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Sharma |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
Department of Anaesthesia, SMS medical college, JLN marg, jaipur
RAJASTHAN
302004
India |
| Phone |
9829566077 |
| Fax |
|
| Email |
drmamtasharma@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Premal Panchal |
| Designation |
Junior Resident |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
Department of Anaesthesia, SMS medical college, JLN marg, jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9116466967 |
| Fax |
|
| Email |
premalpanchal22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia, Sawai Man Singh Medical College, JLN marg, Jaipur, Rajasthan pin code - 302004 |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesia Sawai Man Singh Medical College JLN marg Jaipur |
| Address |
Department of anaesthesia, Sawai Man Singh Medical College, JLN marg, Jaipur, Rajasthan pin code - 302004 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Premal Panchal |
Sawai Man Singh Medical College And Attached Hospitals |
ENT OT, charak bhawan, Department of anaesthesia, JLN marg, Jaipur
Jaipur
RAJASTHAN |
9116466967
premalpancal22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office Of Ethics Committee, SMS Medical College and attached hospitals, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J353||Hypertrophy of tonsils with hypertrophy of adenoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
injection propofol 1mg per kg |
Single dose of injection propofol 1 mg per kg administered intravenously intra operatively at the end of the adenotonsillectomy and will be observed for emergence agitation for 15 minutes in recovery room after surgery completed and patient is extubated |
| Comparator Agent |
Normal saline |
Administration of 10 ml normal saline intravenously at the end of the adenotonsillectomy and patient will be observed for emergence agitation for 15 minutes in recovery room after surgery completed and patient is extubated. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. All elective ASA I & II paediatric patients of either sex, age between 3-10 years
undergoing adenotonsillectomy under general anaesthesia.
2. Patient’s parents willing to give consent. |
|
| ExclusionCriteria |
| Details |
1. Patients part of any other study.
2. Non co-operative patient.
3. Patient with known allergy to propofol.
4. Patient with known psychiatric disorder.
5. Patients having upper respiratory tract infection.
6. Patient requiring intra operative propofol for any indication |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine and compare the incidence (WATCHA scale) and severity (PAED scale) of emergence agitation in both study and control group. |
5 minute, 10 minute, 15 minute |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To determine and compare the emergence time between two groups.
2. To determine side effects and complication if any. |
5 minute, 10 minute, 15 minute |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Emergence agitation is characterised by a state of mental confusion, agitation, and disinhibition marked by some degree of hyperexcitability manifesting as restlessness, agitation, thrashing, crying, moaning, disorientation and incoherence after recovering from anaesthesia. Multiple factors have been identified that affect incidence and severity of emergence agitation like age of the patient, type of surgery ,pain, higher preoperative anxiety level, feeling of suffocation and use of sevoflurane . Higher incidence is found in paediatric age group and patients undergoing ear, nose, throat (ENT) and ophthalmic Post-operative emergence agitation occurring in paediatric patient must be taken a special care because they may deteriorate very rapidly and may put the life of the patient into danger.So it is better to prevent occurrence of emergence agitation rather than cure. With this background we have planned this study to evaluate the effectiveness of prophylactic dose of propofol for prevention of emergence agitation in paediatric patients undergoing
d adenotonsillectomy. |